Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations

Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00235261

Enrollment

120

Registered

2005-10-10

Start date

2005-10-31

Completion date

2007-06-30

Last updated

2007-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Total hip replacement, Pregablin, Dexamethasone, Multimodal postoperative analgesia.

Brief summary

Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.

Detailed description

We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

Interventions

DRUGPregabalin

DRUGDexamethasone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

55 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients scheduled for primary total hip replacement in spinal anaesthesia * between the age of 55 and 75, * ASA 1-3, and with * BMI between 18 and 35.

Exclusion criteria

* are unable to cooperate; * does not speak Danish; * has allergy for drugs used in the trial; * has drug and/or medicine abuse; * epilepsy; * diabetes treated with medicine; * treatment with systemic steroids within 4 weeks prior to the operation; * daily use of antacids; * daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol; * known kidney disease; * use of antidepressants

Design outcomes

Primary

Measure	Time frame
The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)	—

Secondary

Measure	Time frame
Pain score (VAS) at rest and at mobilisation.	—
Postoperative nausea and vomiting.	—
Sedation.	—
Dizziness	—
All measurements are taken at 2,4 and 24 h postoperatively	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026